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U.S. Department of Health and Human Services

Class 2 Device Recall iLab Polaris MultiModality Guidance System

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  Class 2 Device Recall iLab Polaris MultiModality Guidance System see related information
Date Initiated by Firm September 18, 2019
Create Date April 27, 2020
Recall Status1 Completed
Recall Number Z-1804-2020
Recall Event ID 85271
510(K)Number K191008  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Code Information Polaris 2.10 software version (disk batch 629774); iLab Polaris Systems affected product listing (serial numbers): 200204, 200209, 200217, 200308, 200310, 200448, 200450, 200456, 200457, 200458, 200461,200480, 200481, 200103, 200145, 200044, 200118, 200360, 200498, 200170, 8361, 10312, 10443, 10548, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278,10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 6582 , 7023, 7857, 5637, 5716, 6650, 6894, 4031, 5003, 5043, 5060, 5109, 5232, 5239, 5393, 5465, 5651, 5678, 5860, 6193, 6350, 8264, 6819, 6921, 6934, 7332, 7341, 7362, 7733, 7828, 7858, 7933, 7934, 8011, 8155, 8290, 6383, 5182, 5219, 5296, 5398, 8157, 6760, 7723, 10108, 8365, 8367, 10504, 10657, 10501, 4274, 8046, 8048, 5892, 7818, 4773, 5585, 8113, 5165, 4402, 6468, 6319, 5313, 7511, 4952, 5277, 5457, 4116, 5403, 5078, 5664, 5666, 6327, 6733, 6994, 6136, 6206, 6172, 7604, 7602, 7353, 6273, 6993, 4045, 10221, 10261, and 8540.        
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
508-683-4000
Manufacturer Reason
for Recall		 Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
FDA Determined
Cause 2		 Other
Action On September 18, 2019, customers that were upgraded with version 54 of iLab Polaris 2.10 (disk batch 629774) software were sent a customer letter via overnight mail delivery. The letter provides instructions and recommendations to the user until a software upgrade (disk batch 636991) was completed. The firm informed that a firm representative will be in contact with customers directly to schedule a software upgrade at their facilities.The firm advises that systems can continue to be used during the time following the recommendations and instructions within the letter. Additionally, in the firm's Urgent Medical Device Correction notice it explains for Cath Lab Managers or Cath Lab Nurses to perform the following Actions: 1. Distribute the letter to system operators within their facility. 2. Immediately post a copy of Instructions to Archive DFR Data on or in a visible location near each system at their facility. The firm provides the following recommendations: If you possess a system with a serial number listed in the affected product listing note that: 1. After case closure and archiving the DFR data will be stored for only six (6) months on the system. After this timeframe the case will be automatically deleted from the system and cannot be retrieved. 2. The DFR data can be archived on CD/DVD, removable hard drive, or hospital network only by using the True Color SC format. You can ensure your data is archived using the True Color SC format following the "Instructions to Archive DRF Data". 3. Ensure that all cases are archived to prevent data loss. Note that archived cases will be automatically deleted after six (6) months. Additionally, the firm provides the following instructions: The Acknowledgement Form enclosed with the letter (Urgent Medical Device Correction) must be completed and returned even if you do not have any affected units. 1. Immediately post the information in a visible location near the product to ensure the in
Quantity in Commerce 150 units
Distribution OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = Boston Scientific Corporation
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